International Quality Lead

Roche; Mississauga; On-site; CAD 157,000 - 292,000; Full time

Job summary

Genentech, a Roche subsidiary, is seeking a Quality Lead in PDQ to shape quality assurance across development and post-approval products, delivering robust QA strategies and leading global audits.

You will collaborate with international stakeholders, support regulatory inspections, and apply CtQ risk-based thinking to drive continuous improvement in GXP programs.

Qualifications

• Bachelor’s degree or equivalent in a scientific or quality-related field.
• Experience in pharmaceutical, biotech, or medical device industry.
• Strong exposure to global GxP regulations and quality roles (GCP, GVP, IVD/MD).
• Experience with audit management and regulatory inspections.
• Excellent data-driven problem solving and communication.

Responsibilities

• Drive risk-based QA strategies using CtQ framework.
• Plan, perform and lead global audits.
• Collaborate with stakeholders and present observations clearly.
• Support regulatory authority inspection preparation and management.
• Contribute to continuous improvement of PDQ processes.
• Maintain deep awareness of FDA, EU, and ICH guidance across GxP.

Skills

GxP Knowledge

Audit Management

Stakeholder Communication

Data Analytics

Education

Bachelor's degree in science

Job description

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Genentech / Roche!

The Opportunity

Are you ready to shape the future of quality management in healthcare? As a Quality Lead within our Pharma Development Quality (PDQ) division, you will support the Roche/Genentech organisation by developing and delivering robust Quality Assurance strategies, audits, and conclusions across molecules in development, post-approval products, and global processes. You will act as a trusted partner, ensuring our operations maintain the highest standards of compliance while directly influencing how we bring innovative therapies to patients safely and efficiently.

In this dynamic role, you will apply a risk-based approach to Quality Assurance using our Critical to Quality (CtQ) framework. By generating actionable data and insights through audits, you will collaborate closely with international stakeholders and play a vital part in preparing for and supporting regulatory authority inspections. This is an exceptional opportunity to utilise your expertise in a truly global, agile matrix environment where your insights drive continuous improvement.

Key Responsibilities:

• Drive Quality Strategies: Support the execution of risk-based Quality Assurance strategies and conclusions in predominantly Good Pharmacovigilance Practice (GVP) as well Good Clinical Practice (GCP),using the Critical to Quality (CtQ) framework.
• Lead Global Audits: Plan, perform, and lead audits, grouping individual issues into systematic trends to provide valuable quality data that fulfils regulatory requirements.
• Partner with Stakeholders: Establish and maintain strong partnerships with business stakeholders, presenting audit observations and associated compliance risks clearly.
• Support Inspections: Play a key role in regulatory authority inspection preparation and management.
• Advance PDQ Processes: Participate actively in assigned departmental goals and initiatives, contributing directly to the continuous improvement of PDQ processes.
• Maintain GxP Expertise: Maintain deep awareness and expertise in global regulations (such as FDA, EU, and ICH guidance) across GCP, GVP, or Medical Device frameworks.

Who You Are

You are a proactive, analytical quality professional who thrives on transforming complex data into clear, actionable solutions. You are an excellent communicator, highly skilled at collaborating across cultures and influencing stakeholders at various levels with or without formal authority. You look for opportunities to develop your skills within an international team and are passionate about continuous growth.

To be successful in this role, you bring:

• Education: A Bachelor’s degree or equivalent in a scientific or quality-related field, or equivalent combined experience.
• Industry Experience: Proven experience within the pharmaceutical, biotech, or medical device industry, with solid knowledge of end-to-end product operationalisation.
• GxP Knowledge: Strong exposure to and understanding of global GxP regulations and quality roles, specifically within GCP, GVP, or IVD/MD frameworks.
• Data & Digital Literacy: Excellent digital capabilities, with a good understanding of audit management and analytical reporting tools to drive data-led solutions.
• Critical Thinking: Proven problem-solving, decision-making, and project management skills with the ability to navigate ambiguous information.

Location

• This position is based at our South San Francisco, CA campus or Mississauga offices
• Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $111,000 - $206,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company’s policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.